Perineural Versus Systemic Dexamethasone to Prolong Regional Anesthesia in Front Foot Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- time to the first opioids request
研究概览
简要总结
Both perineural and systemic dexamethasone administration allows an increase in analgesic duration of regional anesthesia.
There is a lack of data to determine wich route allows a longer analgesic effect.
This study aims to determine wether perineural dexamethasone allows a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.
详细描述
This is a prospective, randomized, double-blind controlled trial.
All Patients undergoing front foot surgery with metacarpal osteotomy will be screened for inclusion in the protocol. All patients without exclusion criteria will be included in the study.
All patients will receive 30cc mixure of Ropivacaine 0,375% in perineural injection and surgery will be performed under regional anesthesia only. If needed, a sedation with midazolam (1mg) will be performed.
The patients will be randomized over 2 groups:
- "Perineural group":
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •front foot surgery with metacarpal osteotomy under regional anesthesia
- •>18 years old
- •consent to participate in the study
排除标准
- •refusal to participate
- •pregnancy
- •pre existing neuropathy
- •ropivacaine allergy
- •paracetamol allergy
- •liver failure
- •cardiac failure
- •ketoprofen allergy
- •gastric ulcer within the previous year
- •tramadol allergy
- •history of epilepsy
研究组 & 干预措施
Perineural group
1cc (4mg) of dexamethasone will be administrated in perineural injection. 2.5cc of isotonic saline solution will be administrated in systemic injection.
干预措施: Dexamethasone (Drug)
systemic group
1cc of isotonic saline will be administrated in perineural injection. 2.5cc (10mg) of dexamethasone will be administrated in systemic injection.
干预措施: Dexamethasone (Drug)
systemic group
1cc of isotonic saline will be administrated in perineural injection. 2.5cc (10mg) of dexamethasone will be administrated in systemic injection.
干预措施: isotonic saline (Drug)
结局指标
主要结局
time to the first opioids request
时间窗: during the first 48 hours
次要结局
- occurrence of nausea or vomiting(at day 1)
- overall satisfaction regarding pain relief management(at day 1)
- any significant side effects(during the first 7 days after surgery.)